Resection And Partial Liver Segmental Transplantation With Delayed Total Hepatectomy as Treatment for Selected Patients With Unresectable Liver Metastases From Colorectal Carcinoma
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 18
- Locations
- 2
- Primary Endpoint
- Percent of transplanted patients receiving second stage hepatectomy within 4 weeks of segment 2/3 transplantation
Study Overview
Brief Summary
RAPID is an auxiliary liver transplantation where a small liver partial graft (namely left lateral segments from living or cadaveric donors) is implanted orthotopically after a left hepatectomy of the native liver. Subsequently, in order to implement a fast regeneration of the transplanted segments a portal flow diversion is operated in the direction of the future remnant. After obtaining a fast regeneration of the auxiliary future remnant liver the native liver hepatectomy is completed as in a two stage- hepatectomy. Peculiar inclusion criteria will be adopted for patient selection with particular reference to the admission of patients with <3 lung metastases radically treated before transplantation.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •≥ 18 and <70 years
- •Performance status, ECOG 0-1
- •Histologically proved adenocarcinoma in colon or rectum
- •BRAF wild-type CRC on primary tumor or liver metastases
- •High standard oncological surgical resection of the primary tumor
- •Liver metastases not eligible for curative liver resection confirmed by the validation committee
- •At least one line (3 months) of chemotherapy
- •At least 6 months time span from CRC resection and date of being listed on the transplantation list.
- •At least 8 weeks of tumor control: stable disease or partial response according to RECIST 1.1 criteria
- •No signs of extra hepatic metastatic disease or local recurrence on CT, MRI and Pet-CT except patients may have <3 lung lesions all<15mm resected or treated by radiotherapy or metastatic hilar nodes treated by resection and without recurrence at 3 months from resection or radiotherapy.
- •Satisfactory blood tests creatinine in normal level, PLT >60.000/mm3, GB>2500/mm3
- •CEA stable or in decrease
- •Signed informed consent and expected cooperation of the patients for the treatment and follow up
Exclusion Criteria
- •Weight loss >10% the last 6 months
- •Patient BMI > 30
- •Participation refusal
- •General contraindication to LT
- •Other malignancies in the previous 5 years
- •Pregnancy or breast feeding
- •Any reason why, in the opinion of the investigator, the patient should not participate
Outcomes
Primary Outcomes
Percent of transplanted patients receiving second stage hepatectomy within 4 weeks of segment 2/3 transplantation
Time Frame: within 4 weeks from liver transplantation
Rate of second stage hepatectomy performed within 4 weeks from transplatation
Secondary Outcomes
- Mortality(within 90 days from second stage hepatectomy)
- Proportion of drop out(within 100 days from listing)
- Progression free survival(3 and 5 years)
- Intention to treat survival after liver transplantation(3 and 5 years)
- Complication rate(within 90 days after liver transplant)
Investigators
Prof. Umberto Cillo
Prof
Azienda Ospedaliera di Padova